U.S. patent application number 11/342520 was filed with the patent office on 2006-06-08 for femoral intramedullary rod system.
This patent application is currently assigned to Orthodyne, Inc.. Invention is credited to J. Dean Cole.
Application Number | 20060122600 11/342520 |
Document ID | / |
Family ID | 46278613 |
Filed Date | 2006-06-08 |
United States Patent
Application |
20060122600 |
Kind Code |
A1 |
Cole; J. Dean |
June 8, 2006 |
Femoral intramedullary rod system
Abstract
A femoral intramedullary rod system capable of treating a
variety of femoral bone fractures using a uniform intramedullary
rod design. The system generally comprising an intramedullary rod
defining an opening having an upper surface and a transverse member
including a bone engaging portion and a connection portion defining
a thru-hole with the nail sized to pass therethrough. A pin is
selectively coupled to the transverse member to rigidly assemble
the transverse member to the nail when the nail is passed through
the thru-hole and the pin is received within the opening. In an
alternative design, an epiphyseal stabilizer is joined to the nail
by a locking member.
Inventors: |
Cole; J. Dean; (Orlando,
FL) |
Correspondence
Address: |
HAYNES AND BOONE, LLP
901 MAIN STREET, SUITE 3100
DALLAS
TX
75202
US
|
Assignee: |
Orthodyne, Inc.
Orlando
FL
|
Family ID: |
46278613 |
Appl. No.: |
11/342520 |
Filed: |
January 30, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10028325 |
Dec 21, 2001 |
7018380 |
|
|
11342520 |
Jan 30, 2006 |
|
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|
09619189 |
Jul 19, 2000 |
6402753 |
|
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10028325 |
Dec 21, 2001 |
|
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09329688 |
Jun 10, 1999 |
6221074 |
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09619189 |
Jul 19, 2000 |
|
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Current U.S.
Class: |
606/62 |
Current CPC
Class: |
A61B 17/164 20130101;
A61B 17/725 20130101; A61B 17/7225 20130101; A61B 17/72 20130101;
A61B 17/7216 20130101; A61B 17/8685 20130101; A61B 17/744 20130101;
A61B 17/7241 20130101 |
Class at
Publication: |
606/062 |
International
Class: |
A61F 2/30 20060101
A61F002/30 |
Claims
1. A bone fixation apparatus, comprising: an intermedullary nail
having a longitudinal axis and a proximal tip; a blade having a
second longitudinal axis, said blade defining a recess extending in
substantial parallel alignment with said second longitudinal axis,
said recess configured to receive said proximal tip; and locking
member to interconnect said tip and said blade.
2. The apparatus of claim 1, wherein said recess is at least
partially enclosed.
3. The apparatus of claim 2, wherein said recess in enclosed on
three sides and open on a forth side.
4. The apparatus of claim 3, wherein said recess extends along the
second longitudinal axis over at least half of the length of the
blade.
5. The apparatus of claim 1, wherein said blade further includes an
aperture in communication with said recess, said aperture adapted
to received a fastening member configured for engagement with said
tip.
6. The apparatus of claim 5, wherein said aperture is a slot.
7. A method of stabilizing long bone fractures, comprising:
providing an elongate fixation member and a transverse stabilizer
having a recess for receiving at least a portion of the elongate
fixation member; obtaining access to the intermedullary canal of a
long bone; positioning the elongate fixation member in the
intermedullary canal; aligning the recess of the transverse
stabilizer with the tip of the elongate fixation member; driving
the transverse stabilizer in a direction substantially transverse
to the longitudinal axis of the elongate fixation member to thereby
position at least a portion of the elongate fixation member within
the recess of the transverse stabilizer; and interconnecting the
elongate fixation member and the transverse stabilizer.
8. The method of claim 7, wherein said driving includes impacting a
portion of the transverse stabilizer.
9. The method of claim 8, wherein said driving results in sliding
engagement between the recess and the elongate member.
10. A reaming head, comprising: a body having a longitudinal axis
and an outer surface defining a longitudinally extending
substantially cylindrical configuration extending over a majority
of the circumference of said outer surface and a truncated surface
interrupting said substantially cylindrical configuration; a
cutting element positioned in said truncated surface.
11. The reaming head of claim 10, wherein said cutting element is a
blade extending in substantial alignment with said longitudinal
axis.
12. The reaming head of claim 10, further including a rounded
leading surface adjacent said cylindrical configuration.
13. A method of eccentric reaming, comprising: providing a reaming
head having an outer surface with a cylindrical portion and a
cutting element positioned opposite said cylindrical portion and
configured for cutting upon oscillatory motion; inserting the
reaming head into a bone opening; positioning said cylindrical
portion adjacent tissue to be preserved; positioning the cutting
surface adjacent tissue to be removed; oscillating the head of the
reamer to cause the cutting surface to remove tissue.
14. The method of claim 13, wherein said oscillating occurs over a
range of 20 to 180 degrees.
15. The method of claim 14, wherein said oscillating occurs over a
range of 80 to 120 degrees.
16. The method of claim 13, wherein said inserting further includes
positioning a wire guide into the tissue and positioning the reamer
over the wire guide prior to said inserting.
Description
[0001] The present application is a continuation-in-part of U.S.
patent application Ser. No. 09/619,189 filed Jul. 19, 2000 and
claims the priority thereof, which is a divisional of U.S. patent
application Ser. No. 09/329,688 filed Jun. 10, 1999, now U.S. Pat.
No. 6,221,074, each of the above are hereby incorporated by
reference.
FIELD OF THE INVENTION
[0002] The present invention is directed to techniques for treating
bone fractures. Specifically, but not exclusively, the invention
relates to a system for treating a variety of typical femoral
fractures using a uniform intramedullary rod design.
BACKGROUND OF THE INVENTION
[0003] The femur generally comprises an elongated shaft extending
from the hip to the knee. The proximal end of the femoral shaft
includes a neck segment connected to a head portion. The head
portion fits into a concavity of the hip bone to form a ball and
socket joint at the hip. The distal end of the femoral shaft
engages the upper end of the tibia to form the knee joint. Overall,
the femur is one of the longest and strongest bones in the human
body; however, portions of the femur are extremely susceptible to
fracture.
[0004] Internal fixation of femoral fractures is one of the most
common orthopedic surgical procedures. Many different types of
femoral fractures are encountered in practice, including fractures
of the femoral neck, midshaft, and distal regions. When the femur
is fractured, treatment requires that the fractured bone be
substantially immobilized and held together in an abutting
relationship during the healing process. Any longitudinal,
transverse, or rotational movement of one section of the fractured
bone relative to the other can cause substantial delay in healing
time or cause improper healing to occur. In general, two different
internal fixation approaches have been used to immobilize the area
surrounding the fracture site.
[0005] One approach involves driving metallic pins through the two
sections of bone to be joined and connecting them to one or more
plates bearing against the external surface of the bones. However,
such an arrangement injures the flesh and muscle surrounding the
bones and a large number of pins driven through the bone tend to
weaken its hard outer layer. Plates also tend to stress the bone
and are not always able to bear sufficient stress for many femoral
fracture applications.
[0006] Further, bone beneath the plate does not always become as
strong as it would in the absence of the plate. A second approach
to treating femoral fractures involves the use of an intramedullary
nail which is inserted into the medullary canal of the femur and
affixed therein by a number of different methods. After complete
healing of the bone at the fracture site, the nail may be removed
through a hole drilled in the proximal end of the femur. A wide
variety of devices have been developed over the years for use in
the internal fixation of femoral fractures utilizing the method of
intramedullar stabilization and immobilization. While there have
been a number of technological advances made within the area of
intramedullary fixation of femoral fractures, several problem areas
remain.
[0007] One such problem arises from the fact that most
intramedullary fixation systems currently available are adapted to
a specific type of femoral fracture, resulting in a large number of
highly specialized configurations. This has led to the
disadvantageous consequence that hospitals and trauma centers have
to keep a large inventory of incremental nail lengths with varying
configurations and ancillary parts in order to accommodate a random
and diverse incoming patient population. Maintaining such a high
level of inventory to handle all expected contingencies is not only
complex, but is also very expensive. Correspondingly, the
possibility of error during selection and implantation of the
fixation device by the surgeon is elevated. Likewise, the inventory
costs associated with varying methods of intramedullary fixation
are drastically increased and, in the case of smaller medical
facilities, may necessitate switching to a less costly and
potentially less effective method of treating femoral
fractures.
[0008] Another problem may result from intramedullary rod systems
used to specifically treat fractures of the neck or head of the
femur. These devices typically include a transverse fixation member
(nail, pin, screw, etc.) adapted to be positioned along the
longitudinal axis of the femoral neck with its leading end portion
embedded in the femoral head so as to grip the femoral head and
thereby stabilize the fracture site. The fixation member is
operably connected to the intramedullary rod to maintain a fixed
relationship between the fixation member and the rod.
Unfortunately, this structural connection does not always prevent
rotational or translational movement of the fixation member
relative to the intramedullary rod in response to forces commonly
resulting from the normal activity of a convalescing patient.
Additionally, the intramedullary rods used in these devices are
typically specialized for use with this single fixation application
and can not be used in other applications. Therefore, the costs
associated with maintaining increased levels of inventory are
substantially increased. Furthermore, if it is desired to vary the
angle of the fixation member relative to the rod, substantial
modifications must typically be made to either the fixation member
or the rod member to accommodate for such an angular variation,
again driving up inventory levels and associated inventory
costs.
[0009] In still another problem area, on occasion, it is necessary
to use transverse locking bone screws to lock the rod into position
relative to the femur. In order to prevent the screws from backing
out, locking nuts can be threaded onto the distal ends of the
locking screws. Unfortunately, the installation of locking nuts
onto the ends of the locking screws requires additional surgical
incisions and commonly causes soft tissue irritation.
[0010] In yet another problem area, when an intramedullary rod is
inserted into the medullary canal and anchored to the femur by two
or more bone screws, despite the best efforts of the surgeon, the
fracture site may have either been over-compressed or
over-distracted as a result of the insertion of the rod.
Unfortunately, with conventional intramedullary rods, it is
virtually impossible to adjust the amount of distraction or
compression without first removing one or more of the bone screws
and manually distracting or compressing the fracture site. The
intramedullary rod must then be re-anchored to the femur by
reinserting the bone screws at different positions along the
femur.
[0011] Thus, there is a demand for bone treatment techniques to
address these problems. The present invention meets this demand and
provides other benefits and advantages in a novel and unobvious
manner.
SUMMARY OF THE INVENTION
[0012] The present invention is directed to techniques for treating
bone fractures. Various aspects of the invention are novel,
nonobvious and provide various advantages. While the actual nature
of the invention covered herein can only be determined with
reference to the claims appended hereto, selected forms and
features of the preferred embodiment as disclosed herein, are
described briefly as follows.
[0013] One form of the present invention includes treating a bone
fracture with a nail that defines an opening and a transverse
member including a bone engaging portion and a connection portion.
The connection portion defines a through-hole and the nail is sized
to pass through the through-hole. A pin is adjustably coupled to
the transverse member to rigidly assemble the transverse member to
the nail.
[0014] In a further form- of the present invention, a method of
treating a bone fracture includes forming a first hole in a femur
transverse to the medullary canal and introducing a transverse
member through the first hole. The transverse member includes a
through-hole that is positioned relative to the medullary canal of
the femur, and is preferably aligned therewith. The method further
includes forming a second hole intersecting the medullary canal and
inserting an intramedullary nail into the medullary canal via the
second hole. The nail passes through the through-hole of the
transverse member. The nail may include an opening aligned with the
transverse member to facilitate rigid assembly to the transverse
member by positioning a pin coupled to the transverse member in the
nail opening.
[0015] In still another form of the present invention, a system for
treating bone fractures includes a nail having a first end portion
opposite a second end portion along a longitudinal axis. The first
end portion defines an opening extending through the nail and has
an angled surface oriented at an oblique angle relative to the
longitudinal axis of the nail. Also included is a sleeve that
includes a pair of apertures positioned on opposite sides of the
sleeve. The apertures and the opening align to form a passageway
when the sleeve is fitted over an end portion. A bone engaging
member is received within the passageway in an abutting
relationship with the angled surface.
[0016] In yet another form of the present invention, a bone
fracture treatment apparatus includes an elongated nail having a
longitudinal axis and a transverse axis generally perpendicular to
the longitudinal axis. The nail defines a transverse opening
extending along the transverse axis with the opening being bound by
an upper surface and an opposite lower surface. At least one of the
upper or lower surface defines a projection extending in a
longitudinal direction to thereby narrow a dimension of the opening
within the nail. The nail opening, and projection may be arranged
to cooperate with one or more other members suitable to treat a
particular type of bone fracture, such as a fracture of the
femur.
[0017] According to another form of the present invention, a system
for treating bone fractures includes a nail defining a longitudinal
axis, a transverse axis and an opening extending along the
transverse axis with the opening being bound by a bearing surface.
Also included is a sleeve having a pair of apertures positioned on
opposite sides thereof. The apertures and the opening are aligned
to form a passageway when the sleeve is fitted over the nail. A
bone engaging member is sized to pass through the passageway.
Additionally, the system may include a means for biasing the sleeve
in a longitudinal direction to clamp the bone engaging member
against the bearing surface.
[0018] Still a further form of the present invention includes a
technique for treating bone fractures with a nail that defines a
longitudinal axis, an elongated opening extending therethrough, and
a longitudinal passage intersecting the opening. A bone engaging
member passes through the opening and a positioning device is
provided that may be adjusted to change position of the bone
engaging member along the longitudinal axis relative to the nail
when the member is positioned through the nail opening. This device
may be utilized to facilitate compression or distraction of a bone
fracture.
[0019] In yet another embodiment of the present invention, an
epiphyseal stabilizer is provided in conjunction with an
intermedullary nail. In a preferred aspect, the stabilizer includes
a longitudinally extending recess. Preferably, the recess is
adapted to slidingly receive at least a portion of the
intermedullary nail. It is contemplated that a locking member can
be disposed between the stabilizer and nail to maintain their
relative position.
[0020] Still a further aspect of the present invention is an
eccentric reaming head. Preferably, the reaming head includes a
cutting surface positioned along the longitudinal axis and a
substantial portion of the head body opposite the cutting surface
is non-cutting. In a preferred aspect the non-cutting surface is
substantially cylindrical and is configured to guide the cutting
operation away from adjacent surfaces.
[0021] Accordingly, one object of the present invention is to
provide an improved bone fracture treatment system. Preferably,
this system may be used to treat fractures of the femur.
[0022] Additionally or alternatively, another object is to provide
an improved method of treating bone fractures, particularly
fractures of elongated bones such as the femur.
[0023] Additionally or alternatively, still another object is to
reduce the complexity and inventory costs associated with treating
bone fractures.
[0024] Other objects, features, forms, embodiments, aspects,
advantages and benefits of the present invention will become
apparent to persons of ordinary skill in the art from the following
written description and accompanying figures.
BRIEF DESCRIPTION OF THE DRAWINGS
[0025] FIG. 1 is a side view, partly in section, of a rod system of
the present invention with a transverse member shown in an
antegrade position.
[0026] FIG. 2 is a side view, partly in section, of the system of
FIG. 1 with the transverse member in a retrograde position.
[0027] FIG. 3 is a partial side view of the proximal end portion of
the rod of FIGS. 1 and 2.
[0028] FIG. 4 is a partial side view of the sleeve of FIGS. 1 and
2.
[0029] FIG. 5 is a partial, sectional side view of the proximal end
portion of the rod shown in FIG. 3 and the sleeve of FIG. 4
assembled together with the locking member of FIGS. 1 and 2.
[0030] FIG. 6 is a side view, partly in section, of another rod
system of the present invention implanted in the neck and head of a
femur.
[0031] FIG. 7 is a partial, sectional side view of the proximal end
portion of the system of FIG. 6.
[0032] FIG. 8A is a side view of the fixed angle pin of FIG. 7.
[0033] FIG. 8B is an end view of the fixed angle pin of FIG. 7.
[0034] FIG. 9 is a partial, sectional side view of the proximal end
of yet another system of the present invention having a variable
angle pin positioned at 135 degrees relative to a rod.
[0035] FIG. 10A is a side view of the leading portion of the
variable angle pin of FIG. 9.
[0036] FIG. 10B is an end view of the leading portion of the
variable angle pin of FIG. 9 taken along view line 10B-10B of FIG.
10A.
[0037] FIG. 11A is a side view of the trailing portion of the
variable angle pin of FIG. 9.
[0038] FIG. 11B is an end view of the trailing portion of the
variable angle pin of FIG. 9 taken along view line 11B-11B of FIG.
11A.
[0039] FIG. 12 is a partial, sectional side view of the proximal
end of the system of FIG. 9 showing the variable angle pin at 140
degrees relative to the rod.
[0040] FIG. 13 is a side view, partly in section, of still another
rod system of the present invention illustrating implantation of an
intramedullary nail inserted in a retrograde direction.
[0041] FIG. 14 is a partial, sectional side view of the proximal
end portion of a further system of the present invention.
[0042] FIG. 15 is a side view, partly in section, of another rod
system of the present invention for performing distraction of a
bone fracture.
[0043] FIG. 16 is a partial, sectional side view of the proximal
end portion of the rod of FIG. 15.
[0044] FIG. 17 is a partial, sectional side view of the proximal
end portion of the system of FIG. 15, illustrating a first
operational position.
[0045] FIG. 18 is a partial, sectional side view of the proximal
end portion of the system of FIG. 15, illustrating a second
operational position.
[0046] FIG. 19 is a side view, partly in section, of an additional
intramedullary rod system of the present invention for performing
compression of a bone fracture.
[0047] FIG. 20 is a partial, sectional side view of the proximal
end portion of the system of FIG. 19, illustrating a first
operational position.
[0048] FIG. 21 is a partial, sectional side view of the proximal
end portion of the system of FIG. 19, illustrating a second
operational position.
[0049] FIG. 22 is a partial, sectional perspective view of an
epiphyseal stabilizer and intermedullary nail according to another
aspect of the present invention.
[0050] FIG. 23 is a diagrammatic view of the apparatus of FIG. 22
positioned in a femur.
[0051] FIG. 24 is a diagrammatic view of the apparatus of FIG. 22
positioned in a femur.
[0052] FIG. 25A is a top view of an alternative epiphyseal
stabilizer according to the present invention.
[0053] FIG. 25B is an end view of the apparatus of FIG. 25A.
[0054] FIG. 25C is an opposite end view of the apparatus of FIG.
25A.
[0055] FIG. 26A is a top view of a reaming head according to the
present invention.
[0056] FIG. 26B is a side view of the apparatus of FIG. 26A.
[0057] FIG. 26C is an end view of the apparatus of FIG. 26A.
[0058] FIG. 26B is an opposite end view of the apparatus of FIG.
26A.
[0059] FIG. 27 is a cross-sectional view of a bone showing a bone
opening.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0060] For the purposes of promoting an understanding of the
principles of the invention, reference will now be made to the
embodiments illustrated in the drawings and specific language will
be used to describe the same. It will nevertheless be understood
that no limitation of the scope of the invention is thereby
intended, any alterations and further modifications in the
illustrated embodiments, and any further applications of the
principles of the invention as illustrated therein being
contemplated as would normally occur to one skilled in the art to
which the invention relates.
[0061] FIGS. 1-2 depict intramedullary system 10 according to one
embodiment of the present invention. System 10 is shown implanted
in femur 12 and includes an elongated intramedullary rod or nail
14, sleeve 16 and bone engaging member 18. System 10 also includes
fasteners 20 and locking bone screws 22a, 22b. FIG. 1 illustrates
system 10 as used in a first locking configuration with bone
engaging member 18 placed in an antegrade direction within femur
12. FIG. 2 illustrates a second locking configuration of system 10;
where bone engaging member 18 is placed in a retrograde position
within femur 12. The tip of the greater trochanter 12a, the neck
12b, and the head 12c of femur 12 are designated in FIGS. 1 and 2.
Although system 10 is shown implanted in a human femur 12, system
10 could also be used in conjunction with other bones as would
occur to one skilled in the art, including, but not limited to, the
tibia, humerus, radius, ulna and fibula.
[0062] Nail 14 includes a proximal end portion 14a and a distal end
portion 14b. Nail 14 also defines a longitudinal centerline axis
L.sub.1 running along the length of nail 14 between proximal end
portion 14a and distal end portion 14b. For application to an adult
human femur, proximal end portion 14a preferably has a diameter of
about 11-13 millimeters. The diameter of the remainder of nail 14
may vary depending upon the requirements of the fixation procedure
and the surgeon's preference. While nail 14 has a generally
circular cross section, other suitable shapes are also contemplated
as would occur to one skilled in the art.
[0063] Referring additionally to FIGS. 3-5, portion 14b of nail 14
defines generally parallel transverse bores 24a, 24b, each sized to
respectively receive locking bone screws 22a, 22b therein. Distal
end portion 14b also defines transverse bore 24c, aligned generally
perpendicular to transverse bores 24a, 24b and sized to receive
locking bone screw 22c (not shown). Proximal end portion 14a
defines an opening 26 and a threaded transverse bore 28, both
extending through nail 14 generally transverse to axis L.sub.1 from
a first side 14c to a second side 14d. Side 14c generally opposes
side 14d. Proximal end portion 14a also defines threaded
longitudinal bore 29 generally extending along axis L.sub.1 for
receiving nail insertion and extraction instrumentation (not shown)
used to guide nail 14 into and out of femur 12. Nail 14 also
defines a longitudinal passage 30 intersecting bore 29 and
extending generally along axis L.sub.1 to allow for the optional
use of a guide wire (not shown) to aid in the insertion of nail 14
into femur 12.
[0064] Referring more specifically to FIGS. 3 and 5, opening 26 is
bound by lower surface 31 opposite upper surface 32. Lower surface
31 includes a first angled surface 31a oriented generally parallel
to transverse axis To. Upper surface 32 includes a second angled
surface 32a offset from first angled surface 31 a along axis
T.sub.1. Angled surfaces 31a, 32a are generally parallel to
transverse axis T.sub.1. Transverse axis T.sub.1 is aligned at an
oblique angle .alpha..sub.1 relative to longitudinal axis L.sub.1
of nail 14. Angle .alpha..sub.1 is preferably in a range of about
120-150 degrees, with the more preferred angle being about 135
degrees. First angled surface 31a and second angled surface 32a
cooperate to define pathway 33 generally oriented at angle
.alpha..sub.1 relative to axis L.sub.1. First pathway 33 is sized
to receive bone engaging member 18 therethrough.
[0065] Lower surface 31 also includes a third angled surface 31b
aligned generally parallel to transverse axis T.sub.2. Upper
surface 32 also includes a fourth angled surface 32b generally
offset from third angled surface 31b along axis T.sub.2 that is
also generally parallel to transverse axis T.sub.2. Comparing to
FIG. 2, transverse axis T.sub.2 is also aligned at an oblique angle
.alpha..sub.2 relative to longitudinal axis L.sub.1 of nail 14.
Angle .alpha..sub.2 is preferably in a range of about 120-150
degrees, with the more preferred angle being about 135 degrees.
Third angled surface 31b and fourth angled surface 32b cooperate to
define pathway 34 generally oriented at angle .alpha..sub.2
relative to axis L.sub.1. Second pathway 34 is sized to receive
bone engaging member 18 therethrough.
[0066] First angled surface 31a and third angled surface 31b
cooperate to define a first projection 35 extending in a
longitudinal direction which narrows a dimension of opening 26
within nail 14 along axis L.sub.1. Similarly, second angled surface
32a and fourth angled surface 32b cooperate to define a second
projection 36 extending in a longitudinal direction generally
opposite first projection 35 to further narrow a dimension of
opening 26 within nail 14 along axis L.sub.1. In a preferred
embodiment, each projection 35, 36 defines an apex, resulting in a
convergent-divergent throat 36a about midway between sides 14c and
14d of nail 14. However, first projection 35 and second projection
36 could alternatively define any other geometric configuration as
would occur to those skilled in the art. For example, first
projection 35 and second projection 36 could be rounded. Likewise,
in other alternative embodiments, one or more of projections 35, 36
may be absent. While angled surfaces 31a, 31b, 32a, 32b are
generally concave to compliment member 18, other shapes are also
contemplated as would occur to those skilled in the art. For
example, angled surfaces 31a, 31b, 32a, 32b could be flat or have
other configurations corresponding to the outer surface of bone
engaging member 18.
[0067] Referring to FIG. 4, sleeve 16 of system 10 is illustrated
therein. Sleeve 16 has a generally cylindrical shape and defines a
proximal end 16a, a distal end 16b and a side wall 37. Sleeve 16 is
sized to fit over the proximal end of nail 14 as shown in FIG. 3.
Distal end 16b is therefore open to allow for passage of proximal
end portion 14a therethrough. Sleeve 16 also defines an inwardly
tapered edge 38, terminating at distal end 16b, to permit easy
sliding of sleeve 16 through bone. Proximal end 16a defines an
opening 39 to permit access to threaded bore 29, and thus allow for
passage of nail insertion and extraction instrumentation (not
shown). Side wall 37 defines offset apertures 40a, 40b positioned
on opposite sides of sleeve 16. Apertures 40a, 40b are generally
circular and are aligned and sized to receive bone engaging member
18 therethrough. Side wall 37 further defines opposing transverse
apertures 42a, 42b positioned on opposite sides of sleeve 16.
Apertures 42a, 42b are generally circular and are aligned and sized
to receive fastener 20 therethrough.
[0068] Referring to FIG. 5, therein is illustrated bone engaging
member 18. Bone engaging member 18 includes a proximal end portion
18a and a distal end portion 18b. Bone engaging member 18 has a
generally circular cross section and preferably has a diameter of
about 5.5-6.5 millimeters for applications treating fractured adult
human femurs. Distal end portion 18b includes a means for fixedly
engaging and gripping bone 44. Bone engaging member 18 may be a
bone screw having a threaded distal end portion 18b as shown in
FIG. 5, or a bone blade having distal end portion 18b formed from a
plate with a helical twist (not shown). Alternately, distal end
portion 18b may be otherwise configured for engaging bone as would
occur to those skilled in the art.
[0069] As illustrated in FIG. 5, when sleeve 16 is fitted over
proximal end portion 14a of nail 14, apertures 40a, 40b of sleeve
16 are positioned to align with opening 26 of nail 14, and register
with pathway 33 along transverse axis T.sub.1. Collectively,
apertures 40a, 40b and opening 26 define passageway 50 coincident
with pathway 33. Passageway 50 is bound on one side by first angled
surface 31a and on another side by second angled surface 32a. As
bone engaging member 18 is slidably received within passageway 50
and guided along transverse axis T.sub.1, bone engaging member 18
forms an abutting relationship with either or both of first and
second angled surface 31a, 32a. This relationship may be load
bearing in nature. Bone engaging member 18 is sized relative to
passageway 50 so that its rotational position about axis L.sub.1
and its translational position along axis L.sub.1 are generally
fixed when positioned therethrough.
[0070] As illustrated in FIG. 5, when sleeve 16 is fitted over
proximal end portion 14a of nail 14, apertures 42a, 42b of sleeve
16 are aligned with bore 28 of nail 14. A fastener 20 is passed
through aperture 42a and threaded into bore 28 to thereby
releasably secure sleeve 16 to nail 14. Another fastener 20 is
passed through aperture 42b and threaded into bore 28 to further
secure sleeve 16 to nail 14. While two fasteners 20 are shown to
releasably secure sleeve 16 to nail 14, it is also contemplated
that a single fastener may be used to sufficiently secure sleeve 16
to nail 14. To avoid interfering with the optional use of a guide
wire (not shown) to aid in the insertion of nail 14 into femur 12,
fastener 20 has a length which penetrates bore 28 far enough to
secure sleeve 16 to nail 14, but without obstructing longitudinal
passage 30. In still other embodiments, one or more of fasteners
20, bore 28, and apertures 42a, 42b may not be utilized at all.
[0071] Notably, by rotating sleeve 16 180 degrees relative to nail
14, system 10 may be reconfigured from an antegrade orientation of
bone engaging member 18 to a retrograde orientation, or vice-versa.
Similarly, regardless of which locking configuration is used, the
same components of system 10 can be used to treat either a left or
right femur by simply rotating sleeve 16 180 degrees relative to
nail 14. As a result, apertures 40a, 40b of sleeve 16 are
repositioned to align with pathway 34 through opening 26 of nail 14
along transverse axis T.sub.2. Collectively, apertures 40a, 40b and
opening 26 define passageway 52 which is coincident with pathway
34. Passageway 52 is bound on one side by third angled surface 31b
and on another side by fourth angled surface 32b (see FIGS. 2 and
5). As bone engaging member 18 is slidably received within
passageway 52 and guided along transverse axis T.sub.2, bone
engaging member 18 forms an abutting relationship with either or
both of the third and fourth angled surfaces 31b, 32b. Preferably,
this relationship is suitable for load bearing, and generally fixes
member 18 with respect to rotation about axis L.sub.1 or
translation along axis L.sub.1.
[0072] In other embodiments of system 10, the angular alignment of
bone engaging member 18 relative to axis L.sub.1 may be varied by
changing the configuration of sleeve 16. More specifically,
apertures 40a, 40b can be aligned at an angle other than
.alpha..sub.1. In these embodiments, first passageway 50 does not
fall along transverse axis T.sub.1 of nail 14. Thus, as bone
engaging member 18 is slidably received within first passageway 50,
bone engaging member 18 will contact either first projection 35 or
second projection 36, but will not form an abutting relationship
with first angled surface 31a or second angled surface 32a.
However, the alternative arrangement is still suitable to fix bone
engaging member 18 axially and rotationally relative to nail
14.
[0073] Referring again to FIGS. 1 and 2, a femur implantation
procedure corresponding to system 10 is next described. The implant
procedure generally includes forming a longitudinal hole into, and
generally parallel with, the medullary canal from a position
slightly medial to the tip of the greater trochanter 12a. The
longitudinal hole is sized to receive nail 14 therethrough.
Preferably, the longitudinal hole is formed by drilling. Sleeve 16
is fitted over proximal end portion 14a of nail 14 and sleeve 16 is
secured to nail 14 by threading fasteners 20 into bore 28. As
discussed above, system 10 can be used in either a first or second
locking configuration depending on the rotational orientation of
sleeve 16 relative to nail 14.
[0074] FIG. 1 illustrates system 10 in a first locking
configuration corresponding to an antegrade configuration for the
depicted femur 12. In this first locking configuration, sleeve 16
is secured to nail 14 with apertures 40a, 40b positioned relative
to opening 26 of nail 14 to define passageway 52 along transverse
axis T.sub.2. Nail 14, with sleeve 16 secured thereto, is inserted
through the longitudinal hole and into the medullary canal. A
transverse hole is formed through femur 12 across the medullary
canal corresponding to transverse axis T.sub.2. The transverse hole
intersects the medullary canal and is sized to receive bone
engaging member 18 therein. Preferably this transverse hole also is
formed by drilling. Bone engaging member 18 is inserted into the
transverse hole and through passageway 52 formed by nail 14 and
sleeve 16. As a result, member 18 is preferably secured against
translation along axis L.sub.1 or rotation about axis L.sub.1. When
received in passageway 52, member 18 generally extends between a
femur entry point slightly lateral to the greater trochanter 12a to
a terminal point below the base of neck 12b. Generally parallel
bores are formed through femur 12 transverse to the medullary canal
and generally perpendicular to axis L.sub.1 to align with
transverse bores 24a, 24b of nail 14. Preferably these bores are
also formed by drilling. Nail 14 is further locked into position by
inserting locking bone screws 22a, 22b through femur 12 and into
transverse bores 24a, 24b of nail 14.
[0075] FIGS. 2 and 5 illustrates system 10 in a second locking
configuration corresponding to a retrograde arrangement relative to
the depicted femur 12. In this second locking configuration, sleeve
16 is secured to nail 14 with apertures 40a, 40b positioned
relative to opening 26 of nail 14 to define passageway 50 along
transverse axis T.sub.1. The medullary canal is accessed in
generally the same manner as described in connection with FIG. 1.
Nail 14, with sleeve 16 secured thereto, is inserted through the
longitudinal hole medial to the greater trochanter 12a and into the
medullary canal. A transverse hole is drilled into femur 12 across
the medullary canal corresponding to transverse axis T.sub.1 and
sized to receive bone engaging member 18 therein. Bone engaging
member 18 is inserted into the transverse hole through passageway
50. So arranged, member 18 generally extends through neck 12b into
head 12c. Generally parallel bores are formed through femur 12
transverse to the medullary canal and generally perpendicular to
axis L.sub.1. These bores are generally aligned with transverse
bores 24a, 24b of nail 14. Nail 14 is further locked into position
by inserting locking bone screws 22a, 22b through femur 12 and into
transverse bores 24a, 24b of nail 14.
[0076] Next, a preferred method manufacturing nail 14 is described.
This preferred method includes drilling a first bore through
proximal portion 14a in a direction corresponding to transverse
axis T.sub.1 (aligned at angle .alpha..sub.1). A second bore is
then drilled through proximal portion 14a corresponding to
transverse axis T.sub.2 (aligned at angle .alpha..sub.2) and
intersecting the first bore at a point generally corresponding to
the centerline of nail 14. The first and second bores are each
sized to receive bone engaging member 18 therethrough. The first
bore thereby defines first angled surface 31a and second angled
surface 32a, and the second bore thereby defines third angled
surface 31b and fourth angled surface 32b. The remaining material
between lower surface 31 and upper surface 32 may then be removed
to form opening 26 through nail 14, having projections 35, 36 as
depicted.
[0077] FIG. 6 depicts intramedullary system 100 according to
another embodiment of the present invention; where like reference
numerals represent like features previously described in connection
with system 10. System 100 is shown implanted in femur 12 and
includes intramedullary rod or nail 14, transverse member 102, pin
103, locking screw 104 and set screw 105. System 100 also includes
locking bone screws 22a, 22b. Although system 100 is shown
implanted in human femur 12, system 100 could also be used in
conjunction with other bones as would occur to one skilled in the
art, including the tibia, humerus, radius, ulna and fibula to name
a few. While system 100 could be used to treat the same indications
as system 10 in the second locking configuration, as illustrated in
FIG. 2 and discussed above, it is preferably used for fractures of
the proximal portion of femur 12, and more preferably fractures
between the neck 12b and head 12c. The same components of system
100 can be used to treat either a left or right femur by rotating
transverse member 102 180 degrees relative to nail 14.
[0078] FIGS. 7-12 provide additional details concerning the
structure and assembly of system 100. Referring to FIG. 7, various
structural details of transverse member 102 and pin 103 are shown
therein. Transverse member 102 defines a longitudinal centerline
axis L.sub.2 and includes a barrel connection portion 106 and a
bone engaging portion 108. Connection portion 106 is generally
cylindrical and has a side wall 110. Side wall 110 defines a
passage 112 extending generally along axis L.sub.2. Connection
portion 106 also includes a proximal portion 106a and a distal
portion 106b. Proximal portion 106a includes an internal threaded
portion 114 extending along a portion of passage 112. Distal
portion 106b defines an external inward taper 116 to promote ease
of movement through bone when transverse member 102 is advanced
into femur 12. Distal portion 106b also defines an inner retaining
lip 118 for provisionally maintaining bone engaging portion 108 in
sliding engagement with connection portion 106, the operation of
which will become apparent hereinafter.
[0079] A thru-hole 120 is formed through connection portion 106.
Thru-hole 120 is generally cylindrical and has a diameter slightly
greater than the outer diameter of proximal portion 14a of nail 14.
Alternately, thru-hole 120 could be elliptical or any other shape
corresponding to proximal portion 14a of nail 14. Additionally,
thru-hole 120 and portion 14a of nail 14 could be asymmetrical and
of similar profile to prevent rotational movement of transverse
member 102 relative to nail 14 when proximal portion 14a is
received within thru-hole 120. Similarly, if thru-hole 120 and
portion 14a of nail 14 where both tapered in the same direction and
at about the same angle, the resulting tight engagement between
transverse member 102 and nail 14 would aid in preventing
rotational movement.
[0080] Thru-hole 120 is formed through connection portion 102 to
provide a selected angular relationship with axis L.sub.1 when nail
14 passes therethrough. This relationship corresponds to angle
.alpha..sub.3 between axes L.sub.1 and L.sub.2, and is preferably
in a range of about 130-145 degrees. More preferably, for system
100, angle .alpha..sub.3 is about 135 degrees and is equal to angle
.alpha..sub.2 as depicted in FIG. 6. As will become apparent from
later discussion, angle .alpha..sub.3 corresponds to the angle of
fixation between transverse member 102 and nail 14.
[0081] Bone engaging portion 108 includes a proximal portion 108a
and a distal portion 108b. A bone engaging and gripping thread 122
is formed on distal portion 108b. Additionally or alternatively, a
different bone gripping means may be utilized, such as a bone blade
having distal portion 108b formed from a plate with a helical
twist, or such other means as would occur to those skilled in the
art.
[0082] Proximal portion 108a includes a hex recess 124 for
receiving a driving tool (not shown), such as an Allen wrench,
preferably suited to drive bone engaging portion 108 into neck 12b
and head 12c of femur 12. Bone engaging portion 108 defines a
longitudinal passage 126 extending therethrough and generally along
axis L.sub.2 to allow for the optional use of a guide wire (not
shown) to aid in the insertion of bone engaging portion 108 into
bone. Proximal portion 108a is sized to be received within passage
112 of connection portion 106 to allow slidable movement of bone
engaging portion 108 generally along axis L.sub.2 over a
predetermined range. A keeper 128 is provided on, in association
with, or integral to proximal portion 108a to provisionally
maintain bone engaging portion 108 and connection portion 106 in a
telescopic sliding relationship. Keeper 128 is comprised of a
cylindrical sleeve that is preferably laser welded onto shaft 130
of bone engaging portion 108 after it has been positioned within
connection portion 106. The outer diameter of keeper 128 is
slightly smaller but in close tolerance with the inner diameter of
passage 112.
[0083] Pin 103 is shown positioned within passage 112 of connection
portion 106. FIGS. 8A and 8B additionally illustrate various
structural details of pin 103. Pin 103 has a longitudinal
centerline axis L.sub.3 and includes a leading portion 132
integrally connected to a trailing portion 134. Leading portion 132
has a generally circular, elongated body and is sized to be
received within opening 26 of nail 14. Leading portion 132 also
includes an angled, annular engaging surface 135 configured to
co-act with a surface of nail 14. Engaging surface 135 is aligned
at an angle .alpha..sub.4 relative to axis L.sub.3. Angle
.alpha..sub.4 is in a range of about 130-145 degrees. Most
preferably, angle .alpha..sub.4 should be approximately equal to
angle .alpha..sub.2. Leading portion 132 additionally includes a
tapered tip 136. Trailing portion 134 is provided with an
externally threaded portion 137 configured to threadedly engage
threaded portion 114 of connection portion 106. A hex recess 138 is
defined by trailing portion 134 for receiving a driving tool (not
shown), such as an Allen wrench, to advance pin 103 into portion
106 or remove pin 103 from portion 106 by turning in a
corresponding rotational direction. In other embodiments, pin 103
additionally or alternatively has a different means for positioning
relative to connection portion 106, such as a ratcheting mechanism,
a cabling arrangement, or any other method capable of advancing pin
103 along axis L.sub.2 as would occur to those skilled in the
art.
[0084] In order to prevent pin 103 from migrating once positioned
in a desired position within passage 112, system 100 includes
locking screw 104. Locking screw 104 is provided with external
threads 142 configured to threadedly engage threaded portion 114 of
connection portion 106. A hex recess 144 is defined by trailing end
146 for receiving a driving tool (not shown), such as an Allen
wrench, to rotationally advance locking screw 104 along connection
portion 106. Locking screw 104 is axially advanced along axis
L.sub.2 until it tightly engages trailing portion 134 of pin 103.
In other embodiments; system 100 additionally or alternatively
includes another locking means as would normally occur to one
skilled in the art to prevent pin 103 from migrating relative to
connection portion 106.
[0085] To further aid in preventing pin 103 from rotating,
loosening or migrating once positioned in a desired axial position
within passage 112, system 100 includes set screw 105. Set screw
105 includes a threaded portion 150 and an elongated stem portion
152. Threaded portion 150 is configured to threadedly engage bore
29 of nail 14. Threaded portion 150 also includes a hex recess 154
for receiving a driving tool (not shown), such as an Allen wrench,
to rotationally advance set screw 105 along bore 29. Elongated stem
portion 152 is sized to be slidably received within longitudinal
passage 30 of nail 14. Stem 152 also defines a tapered or contoured
end 156 conforming with an outer surface of leading portion 132 of
pin 103 to provide improved mechanical interlocking between set
screw 105 and pin 103.
[0086] Referring generally to FIGS. 6, 7, 8A, and 8B, another
embodiment of a femur implantation procedure in accordance with the
present invention is described with respect to system 100. This
femur implantation procedure generally includes forming a
transverse passage into femur 12 that crosses the medullary canal
and is sized to receive transverse member 102 therein. Preferably,
this transverse passage is formed by drilling and begins at the
lateral side of femur 12, extends into neck 12b and terminates in
head 12c to orient transverse member 102 as depicted in FIG. 6.
Also shown in FIG. 6, it is preferred that the transverse passage
form an oblique angle approximately the same as angle .alpha..sub.3
with respect to axis L.sub.1 or the medullary canal.
[0087] Next, transverse member 102 is introduced through the
transverse passage with thru-hole 120 positioned to at least
overlap the medullary canal of femur 12, and preferably to be
generally centered with respect to the medullary canal of femur 12.
At least a portion of bone engaging portion 108 is threaded into
femur 12 at this stage. Preferably, bone engaging portion 108 is
threaded into a portion of head 12c of femur 12 by engaging hex
recess 124 with a suitable tool and turning portion 108 in a
corresponding rotational direction generally about axis
L.sub.2.
[0088] Notably, bone engaging portion 108 is telescopically
received within passage 112 of connection portion 106 to allow
axial movement of bone engaging portion 108 over a predetermined
range along axis L.sub.2. Keeper 128 cooperates with inner
retaining lip 118 to prevent disengagement of bone engaging portion
108 from connection portion 106. The cooperation between inner
retaining lip 118 and keeper 128 also acts to stabilize bone
engaging portion 108, thus aiding in the sliding motion of bone
engaging portion 108 to provide the preferred telescopic
functioning of transverse member 102. Since connection portion 106
provisionally maintains bone engaging portion 108 in a captive,
telescopic relationship, the alignment of bone engaging portion 108
along axis L.sub.2 is always maintained. Thus, when the procedure
includes turning thread 122 through neck 12b of femur 12 and into
head 12c, head 12c will become fixed in an angular relationship
relative to transverse member 102. By maintaining the angular
alignment between neck 12b and head 12c, and allowing them to slide
telescopically relative to one another, system 100 can accommodate
for changes during patient movement and expedite the bone healing
process.
[0089] After transverse member 102 is inserted, an opening is
formed, preferably by drilling, into and generally along the
medullary canal from a position slightly medial relative to the tip
of the greater trochanter 12a and sized to receive nail 14
therethrough. Nail 14 is inserted through the longitudinal hole and
into the medullary canal. Nail 14 passes through thru-hole 120 of
connection portion 106. Thru-hole 120 of transverse member 102
receives nail 14 in a close sliding fit, thereby permitting limited
axial and rotational movement of transverse member 102 along axis
L.sub.1 of nail 14. Transverse member 102 is longitudinally
positioned on nail 14 so that passage 112 of connection portion 106
registers with opening 26 of nail 14. If desired, bone engaging
portion is further advanced into the bone at this stage.
[0090] Next, pin 103 is axially advanced through passage 112 by
engaging hex recess 144 with an appropriate tool and rotating in a
corresponding direction. As threaded portion 137 of pin 103 engages
threaded portion 114 of connection portion 106, leading portion 132
is slidably received within opening 26 to engage one or more
surfaces 31b, 32b. Even if passage 112 and opening 26 are
misaligned, in many instances tapered tip 136 allows pin 103 to
self-center, thereby aiding in the insertion of leading portion 132
within opening 26. As pin 103 is slidably received within pathway
34 of opening 26 and guided along transverse axis T.sub.2, leading
portion 132 forms an abutting relationship with one or both of
angled surfaces 31b, 32b. Pin 103 thus becomes oriented at angle
.alpha..sub.2 relative to axis L.sub.1, aiding in the fixation of
transverse member 102 relative to nail 14. As pin 103 is further
advanced through passage 112, engaging surface 135 is firmly
pressed against nail 14 and transverse member 102 is pulled in a
proximal direction. Correspondingly, an inner surface of transverse
member 102 that borders thru-hole 120 is clamped against an outer
surface of nail 14 while generally maintaining angle .alpha..sub.2
of transverse member 102 relative to axis L.sub.1.
[0091] After securely clamping transverse member 102 and nail 14
together, generally parallel passages are formed, preferably by
drilling through femur 12 transverse to the medullary canal and
aligned with transverse bores 24a, 24b of nail 14. Nail 14 is
further locked into position by inserting locking bone screws 22a,
22b through femur 12 and into transverse bores 24a, 24b of nail
14.
[0092] Referring to FIG. 9, system 160 of another embodiment of the
present invention is illustrated; where reference numerals like
those of previously embodiments refer to like features. System 160
includes transverse member 102' which is the same as transverse
member 102 except that pin 103' is utilized in place of pin 103.
FIGS. 10A, 10B, 11A and 11B illustrate selected details of pin
103'. Pin 103' includes a leading portion 162 and a non-integral
trailing portion 164. Leading portion 162 preferably has a
generally circular, elongated body and is sized to be received
within opening 26 of nail 14. Leading portion 162 also includes an
angled, annular engaging surface 165 configured to co-act with a
surface of nail 14. Engaging surface 165 is aligned at an angle
.alpha..sub.4 relative to axis L.sub.4 of pin 103'. Leading portion
162 additionally includes a tapered tip 166.
[0093] Leading portion 162 is articulated to trailing portion 164
to facilitate pivotal movement of portion 162 relative to portion
164. Trailing portion 164 includes externally threaded portion 167
configured to threadedly engage threaded portion 114 of connection
portion 106. A hex recess 168 is defined by trailing portion 164
for receiving a driving tool (not shown), such as an Allen wrench,
to advance pin 103 axially along connection portion 106. In other
embodiments, pin 103' is alternatively or additionally configured
with a different means to be axially advanced through connection
portion 106, such as a ratcheting mechanism or a cabling
arrangement. In still other embodiments, techniques are utilized as
would occur to one skilled in the art.
[0094] Leading portion 162 has a longitudinal centerline axis
L.sub.4 and trailing portion 164 has a longitudinal centerline axis
L.sub.5. Unlike pin 103, leading portion 162 and trailing portion
164 are not integral and are coupled to permit leading portion 162
to pivot relative to trailing portion 164. This pivoting or
articulation permits angular variation of portion 162 relative to
axis L.sub.2. In one preferred embodiment, leading portion 162
includes a ball and socket joint 170 to provide the angular
adjustment capability.
[0095] The rear portion of leading portion 162 defines a concave
surface 174 generally centered about axis L.sub.4. Projecting
proximally from concave surface 174 along axis L.sub.4 is stem 178.
Stem 178 has a generally circular cross section, but also
preferably defines a pair of parallel, opposing flats 180a, 180b. A
ball member 182 is positioned at the end of stem 178 and is
generally spherical-shaped. Trailing portion 164 defines a convex
surface 184 generally centered about axis L.sub.5 and configured to
closely conform with concave surface 174 of leading portion 162.
Trailing portion 164 also defines a transverse socket 186 extending
partially therethrough and aligned generally perpendicular to axis
L.sub.5.
[0096] Transverse socket 186 has a diameter slightly larger than
the diameter of ball member 182. Transverse socket 186 terminates
at concave bottom surface 188. Concave bottom surface 188
substantially conforms with the outer surface of ball member 182.
Trailing portion 164 also defines a longitudinal bore 190 aligned
with axis L.sub.5. Longitudinal bore 190 extends from convex
surface 184 to transverse socket 186. Longitudinal bore 190 is
outwardly tapered with wide end 190a intersecting convex surface
184 and narrow end 190b intersecting transverse socket 186, thus
defining taper angle as relative to axis L.sub.5. Preferably, taper
angle .alpha..sub.5 is between about 5 degrees and 20 degrees. Most
preferably, taper angle .alpha..sub.5 is about 10 degrees. Trailing
portion 164 further defines a transverse slot 192 extending
partially therethrough and substantially aligned with transverse
socket 186. Slot 192 has a width W extending along longitudinal
bore 190 from convex surface 184 to transverse socket 186. Slot 192
has a depth sufficient to intersect narrow end 190b of transverse
bore 190. Height H of slot 192 is slightly greater than the
distance between flats 180a, 180b of stem 190. Collectively, socket
186 and slot 192 are configured to receive ball member 182 and stem
178 therein, respectively.
[0097] In another embodiment of pin 103', a flexible, readily
deformable intermediate section is positioned between leading
portion 162 and trailing portion 164 that may be additionally or
alternatively used to provide means for allowing angular variation
between axis L.sub.4 and axis L.sub.5. In still another embodiment,
portion 162 is journaled to portion 164 by a shaft through a bore,
permitting rotation of portion 162 relative to portion 164. In
other embodiments, another suitable means for providing angular
variation between axis L.sub.4 and L.sub.5 may alternatively or
additionally be utilized as would occur to those skilled in the
art.
[0098] As illustrated in FIG. 9, pin 103' operates generally in the
same manner as pin 103 described in connection with system 100.
Although pin 103' can be used in instances where angles
.alpha..sub.2 and .alpha..sub.3 are substantially equal (as shown
in FIG. 9), the more preferred application arises in configurations
where angles .alpha..sub.2 and .alpha..sub.3 are different. The
articulation of leading portion 162 relative to trailing portion
164 facilitates secure clamping to nail 14 despite a mismatch
between the angled surfaces 31a, 32a, or 31b, 32b and the angular
relationship of member 102' to axis L.sub.1 defined by thru-hole
120. For example, referring additionally to FIG. 12, angles
.alpha..sub.2 and .alpha..sub.3 are about 135 and 140 degrees,
respectively, relative to axis L.sub.1. Preferably, the pivot range
of leading portion 162 accommodates a range of different angular
orientations of thru-hole 120 corresponding to .alpha..sub.3. In
one more preferred range, leading portion 162 pivots to accommodate
a variation of angle .alpha..sub.3 from about 130 to about 145
degrees.
[0099] In one preferred implantation procedure, transverse member
102' and nail 14 are implanted in accordance with the same
procedure for inserting bone engaging member 108, connection
portion 106 and nail 14, with the engagement of pin 103' in place
of pin 103. For pin 103', ball member 182 is inserted into socket
186 by aligning flats 180a, 180b of stem 178 with slot 192 and then
guiding ball member 182 within transverse socket 186 until ball
member 182 is positioned adjacent concave bottom surface 188. A
slight rotation or angulation of leading portion 162 relative to
trailing portion 164 securely engages the two portions. As a
result, leading portion 162 is rotatably coupled to trailing
portion 164 by ball and socket joint 170. Thus, leading portion 162
can rotate freely over a predetermined range within passage 112 as
limited by taper angle .alpha..sub.5. In one preferred embodiment,
taper angle as permits angular variation between leading portion
162 and trailing portion 164 of about 10 degrees in any direction.
The assembly of leading portion 162 to trailing portion 164 may be
performed during the implantation procedure just before insertion
into passage 112 or in advance of the procedure as desired.
[0100] Once leading portion 162 and trailing portion 164 are
assembled, Pin 103' is advanced through passage 112 of connection
portion 106 by engaging hex recess 168 and turning in the
appropriate rotational direction. Pin 103' is slidably received
within pathway 34 of opening 26 and leading portion 162 is guided
along transverse axis T.sub.2 to form an abutting relationship with
one or both of angled surfaces 31b, 32b. If, as mentioned above,
thru-hole 120 is disposed in connection portion 106 in
correspondence to a different angle .alpha..sub.3 relative to axis
L.sub.1 (such as 140 degrees), leading portion 162 is forced to
pivot relative to trailing portion 164 and thereby aligns at angle
.alpha..sub.2 (such as 135 degrees). As trailing portion 164 is
tightened in connection portion 106, a rigid, secure construct
forms between transverse member 102' and nail 14 as described in
connection with the operation of system 100, except that pin 103'
may pivot, contacting an inner surface of connection portion 106 as
illustrated in FIG. 12. Notably, like system 10, system 100 and 160
may be reconfigured to accommodate either the left-or right femur
or an antegrade or retrograde application; however, in other
embodiments of the present invention, rod 14 may be modified to
define only one generally linear pathway therethrough.
[0101] Referring now to FIG. 13, system 195 according to another
embodiment of the present invention is illustrated; where reference
numerals of previously described embodiments refer to like
features. Preferably, system 195 is implanted in femur 12 as shown,
and includes intramedullary rod or nail 14, set screw 105, and
locking bone screws 22a, 22b, 22c. In other embodiments, system 195
may be used in conjunction with other bones as would occur to one
skilled in the art, such as the tibia, humerus, radius, ulna, or
fibula to name a few. Additionally, the same components of system
195 can be used to treat either a left or right femur by simply
rotating nail 14 180 degrees relative to longitudinal axis L.sub.1.
Unlike systems 10, 100 and 160; system 195 positions nail 14 with
the proximal and distal end portions reversed within femur 12
corresponding to implantation of nail 14 in a retrograde direction.
Unlike existing systems, nail 14 need not be modified to operate in
a retrograde direction. Indeed, nail 14 may be used in either an
antegrade direction, as illustrated in connection with systems 10,
100, and 160, or a retrograde direction as illustrated in FIG.
13.
[0102] One preferred implant procedure for system 195 includes
forming a longitudinal hole along femur 12, intersecting the
medullary canal from a point generally central to distal end
portion 12d. The longitudinal hole is sized to receive nail 14
therethrough and is preferably formed by drilling into femur 12.
Nail 14 is inserted through the longitudinal hole and into the
medullary canal. A pair of generally parallel, transverse
passageways are formed, preferably by drilling, through femur 12
transverse to and intersecting with the medullary canal. These
passageways are in registry with opening 26 and transverse bore 28,
respectively. Nail 14 is locked into position by inserting locking
bone screws 22a, 22b into the transverse passageways and
correspondingly through opening 26 and transverse bore 28. Another
transverse passageway is drilled through femur 12 across the
medullary canal and intersecting therewith that is generally
aligned with transverse bore 24c formed in distal portion 14b of
nail 14. Nail 14 is further locked into position by inserting
locking bone screw 22c into this distal transverse passageway and
correspondingly through transverse bore 24c. Although system 195
does not require a sleeve to lock bone screws 22a, 22b into
position relative to nail 14, as discussed below, such a feature
may optionally be utilized.
[0103] Referring now to FIG. 14, shown is bone treatment system 200
according to yet another embodiment of the present invention; where
reference numerals of previously described embodiments refer to
like features. System 200 is shown implanted in femur 12 and
includes intramedullary nail 14, sleeve 202, bone engaging members
204, 205 and biasing sleeve 202. Preferably, system 200 is utilized
to treat fractures of the human femur, but may be used in
conjunction with any other bone as would occur to those skilled in
the art. Additionally, while system 200 can be used with any nail
and sleeve configuration, it is preferably used in conjunction with
retrograde implantation of nail 14 as described in connection with
FIG. 13 herein.
[0104] In FIG. 14, opening 26 extends generally along transverse
centerline axis T.sub.3 and transverse bore 28 extends generally
along transverse centerline axis T.sub.4. Opening 26 is bounded by
a bearing surface 26a and bore 28 is bounded by a bearing surface
28a. Sleeve 202 has a generally cylindrical shape and defines a
proximal end 202a, a distal end 202b, and a side wall 208. Sleeve
202 is sized to fit over proximal end portion 14a of nail 14.
Distal end 202b is therefore open to allow for passage of proximal
end portion 14a. Sleeve 202 defines an inwardly tapered edge 210,
terminating at distal end 202b, to facilitate movement of sleeve
202 through bone. Proximal end 202a is also open to allow for the
passage of nail insertion and extraction instrumentation (not
shown). The interior surface of side wall 208 immediately adjacent
proximal end 202a defines a threaded portion 211. Side wall 208
also defines two sets of opposing apertures 212a, 212b and 214a,
214b. Apertures 212a, 214a oppose apertures 212b, 214b in a
direction along axes T.sub.3, T.sub.4, respectively. Aperture sets
212a, 212b, and 214a, 214b are generally circular and are aligned
and sized to respectively receive bone engaging members 204, 205
therethrough. Apertures 212a, 212b define circumferential engaging
surfaces 213a, 213b, respectively, and apertures 214a, 214b define
circumferential engaging surfaces 215a, 215b, respectively.
[0105] Bone engaging member 204 includes a proximal end portion
204a opposite a distal end portion 204b. Bone engaging member 204
has a generally circular cross section and preferably has a
diameter of about 5.5-6.5 millimeters for a femur application.
Distal end portion 204b includes thread 216 for engaging and
gripping bone. Alternatively or additionally, member 204 may
include a different bone engaging or gripping means such as a bone
blade having distal end portion 204b formed from a plate with a
helical twist or an expansion device. Bone engaging member 205
includes a proximal end 205a and a distal end 205b and is
preferably configured the same as bone engaging member 204.
[0106] System 200 includes biasing end cap 220. End cap 220 is
generally circular and includes a first threaded portion 222
configured to threadingly engage threaded portion 211 of sleeve
202. A second threaded portion 224 is configured to threadingly
engage longitudinal bore 29 of nail 14. End cap 220 proximally
terminates in an enlarged, flat end portion 226 having protruding
flange 228. Flat end portion 226 also defines hex recess 230 for
receiving a driving tool (not shown).
[0107] System 200 is utilized in accordance with one preferred
femur implantation procedure by inserting nail 14 as described in
connection with FIG. 13, except, proximal end 14a also carries
sleeve 202 thereon by loosely threading end cap 220 into sleeve 202
and rod 14. Accordingly, protruding flange 228 of flat end portion
226 bears against proximal end 202a of sleeve 202. With sleeve 202
so oriented, apertures 212a, 212b are generally in alignment with
transverse bore 28 along axis T.sub.4 to define passageway 232.
Correspondingly, apertures 214a, 214b are generally aligned with
opening 26 along transverse axis T.sub.3 to defined passageway
234.
[0108] Once the nail 14 and sleeve 202 are in place within femur
12, two transverse passages are formed through the bone that are in
registry with passageways 232, 234. Next, bone engaging members
204, 205 are received through the bone and passageways 232, 234,
respectively. Once bone engaging members are in place. Sleeve 202
is biased by further tightening of end cap 220. As end cap 220 is
tightened, is moves sleeve 202 and nail 14 in opposite directions
along axes L.sub.1. Correspondingly, surfaces 213a, 213b move to
bear against bone engaging member 204 and engaging surfaces 214a,
214b bear against bone engaging member 205. In turn, bone engaging
member 204 is tightly clamped against bearing surface 26a of
opening 26 and bone engaging member 205 is tightly clamped against
bearing surface 28a of bore 28. The tight engagement between bone
engaging members 204, 205 and bearing surfaces 26a, 28a thereby
clamps bone engaging members 204, 205 into position relative to
nail 14 and prevents lateral migration. Locking nuts, which have in
the past been used to prevent such lateral migration, are generally
not needed for system 200, so that additional surgical incisions
normally required to engage locking nuts onto the bone engaging
members need not be made and soft tissue irritation commonly
associated with the presence of the locking nuts is also
eliminated. Preparations and implantation of one or more bone
engaging members may optionally be performed at distal end 14b of
nail 14.
[0109] In an alternative embodiment, end cap 220 does not include
first threaded portion 222. Thus, as threaded portion 224 engages
longitudinal bore 29 of nail 14, flange 228 of flat end portion 226
contacts proximal end 202a of sleeve 202 to advance sleeve 202 in a
distal direction relative to nail 14. In still another embodiment,
end cap 220 does not include second threaded portion 224. Thus, as
threaded portion 222 engages threaded portion 211 of sleeve 202,
flat end 222a of threaded portion 222 is forced into contact with
the proximal end of nail 14, thereby advancing sleeve 202 in a
proximal direction relative to nail 14. In yet another embodiment
of system 200, the biasing means consists of a spring member
operably captured between nail 14 and sleeve 202. The spring member
is configured to urge sleeve 202, nail 14, or both to clamp bone
engaging members 204, 205.
[0110] Referring now to FIG. 15, intramedullary system 300
according to still another embodiment of the present invention is
illustrated; where reference numerals of previously described
embodiments refer to like features. System 300 is shown implanted
in femur 12 and includes elongated intramedullary nail 302,
positioning device 304, bone engaging member 306 and locking bone
screw 308. Femur 12 includes a fracture site 301, separating femur
12 into two portions 12f, 12e. Fracture site 301 is shown in a
compressed state (i.e., portions 12f, 12e are being pushed
together). Although system 300 is shown implanted in femur 12,
system 300 could also be used in conjunction with other bones such
as the tibia, humerus, radius, ulna and fibula to name a few.
Additionally, the same components of system 300 can be used to
treat either a left or right femur by simply rotating nail 302 180
degrees relative to axis L.sub.6. Although FIG. 15 illustrates nail
302 implanted within femur 12 in a retrograde direction, it is
understood that system 300 could also be implanted with nail 302 in
an antegrade direction.
[0111] FIGS. 15 and 16 show various structural details of nail 302.
It should be understood that nail 302 can take on a number of
configurations, including that of nail 14 illustrated and described
above. However, in a preferred embodiment, nail 302 is configured
as described below. Nail 302 includes a proximal end portion 302a
and a distal end portion 302b. Nail 302 also defines a longitudinal
axis L.sub.6 running along the length of nail 302 between proximal
end portion 302a and distal end portion 302b. Proximal end portion
302a preferably has a diameter of about 11-12 millimeters for an
adult human femur application. The diameter of the remainder of
nail 302 can be varied depending upon the requirements of the
fixation procedure and the surgeon's preference. While nail 302 has
a generally circular cross section, other suitable shapes are also
contemplated as would occur to one skilled in the art.
[0112] Nail 302 defines a passage 309 extending therethrough along
axis L.sub.6 line to allow for the optional use of a guide wire
(not shown) to aid in the insertion of nail 302 in femur 12. Distal
end portion 302b defines parallel transverse bores 310b, 310c, each
sized to receive locking bone screw 308. Distal end portion 302b
also defines transverse bore 310a, aligned generally perpendicular
to transverse bores 310b, 310c and also sized to receive locking
bone screw 308.
[0113] Proximal end portion 302a defines an elongated, longitudinal
opening 312 bounded by side walls 313 and sized to receive bone
engaging member 306 therein. Opening 312 laterally extends through
nail 302 and is elongated in the direction of longitudinal axis
L.sub.6. Opening 312 has a first end portion 312a and an opposing
second end portion 312b. Proximal end portion 302a of nail 302 also
defines a longitudinal passage 314 extending generally along axis
L.sub.6 and having a generally circular cross-section. Longitudinal
passage 314 intersects opening 312 and terminates in a generally
concave bottom surface 316. A threaded portion 318 is defined about
a portion of longitudinal passage 314. Proximal end portion 302a
also defines a transverse bore 320 extending through nail 302
generally perpendicular to axis L.sub.6 and aligned with opening
312. Bore 320 is sized to receive bone engaging member 306
therein.
[0114] Referring to FIG. 17, therein is shown nail 302, positioning
device 304 and bone engaging member 306 as assembled within system
300. Positioning device 304 is shown positioned within longitudinal
passage 314 and includes a first portion 322 and a second portion
324. First portion 322 includes a head 326 and a threaded stem 328
extending therefrom generally along longitudinal axis L.sub.6. Head
326 is substantially circular and has an outer diameter generally
corresponding to the outer diameter of nail 302. Head 326 also
includes a hex recess 330 for receiving a driving tool (not shown),
such as an Allen wrench. The diameter of threaded stem 328 is less
than the diameter of head 326, thereby defining an annular shoulder
332.
[0115] Second portion 324 defines a generally circular, elongated
body 333 having a diameter slightly less than the diameter of
longitudinal passage 314. Second portion 324 also defines an
internally threaded portion 334 extending generally along
longitudinal axis L.sub.6 and configured to threadedly engage
threaded stem 328 of first portion 322. Threaded portion 334 has a
depth slightly greater than the length of threaded stem 328. The
end of second portion 324 opposite threaded portion 334 terminates
into a generally convex outer surface 336 that substantially
corresponds to concave bottom surface 316 of longitudinal passage
314. Second portion 324 also defines a transverse opening 338
extending therethrough generally perpendicular to longitudinal axis
L.sub.6. Opening 338 is bounded by inner surface 339 and is sized
to receive bone engaging member 306 therein.
[0116] FIG. 17 illustrates a first operational position of system
300. Positioning device 304 (including first and second portions
322, 324) is shown inserted within longitudinal passage 314 of nail
302. Opening 338 of second portion 324 is positioned adjacent
second end portion 312b of opening 312 and generally aligned with
opening 312 to define a passageway 340. Bone engaging member 306 is
shown inserted through passageway 340. Threaded stem 328 of first
portion 322 is partially threadedly engaged within threaded portion
334 of second portion 324. First portion 322 can be rotated by
placing a driving tool (not shown) within hex recess 330 and
turning in a clockwise or counterclockwise direction as
appropriate. Second portion 324 is prevented from rotating in
correspondence with first portion 322 because of engagement between
bone engaging member 306 against sidewalls 313 of opening 312. In
one embodiment, threaded stem 328 and threaded portion 334 each
have right-handed threads. In this embodiment, as first portion 322
is rotated in a clockwise direction, shoulder 332 of head 326 bears
against nail 302, and second portion 324 correspondingly moves
toward first portion 322 generally along longitudinal axis L.sub.6.
As the position of second portion 324 is adjusted along axis
L.sub.6, inner surface 339 of opening 338 bears against bone
engaging member 306 and correspondingly adjusts the position of
bone engaging member 306 along the length of opening 312.
[0117] FIG. 18 illustrates a second operational position of system
300 in which first portion 322 is rotated in a clockwise direction
until bone engaging member 306 is positioned adjacent first end
portion 312a of opening 312. It should be understood, however, that
bone engaging member 306 can be variably positioned anywhere along
the length of opening 312. It should further be understood that the
terms "first operational position" and "second operational
position" are not necessarily indicative of the initial position
and adjusted position of bone engaging member 306. For example,
bone engaging member 306 could originate in a position adjacent
first end portion 312a and be variably positioned anywhere along
the length of opening 312.
[0118] In other embodiments of system 300, nail 302 defines a
keyway extending along the length of longitudinal passage 314
generally parallel with axis L.sub.6. Additionally, second portion
324 defines a key along its length which generally corresponds to
the keyway defined in nail 302. Preferably, the key is radially
positioned so that when it is slidably received within the keyway,
opening 338 of second portion 324 will correspondingly align with
opening 312 of nail 302. Alternatively, the key could be defined
along the length of second portion 324 and, correspondingly, the
keyway could be defined along the length of longitudinal passage
314 of nail 302.
[0119] Having described selected structural and operational
features of nail 302 and positioning device 304, the operational
characteristics of system 300 will now be described in further
detail. Referring back to FIG. 15, nail 302 is shown implanted-in
femur 12. Distal end 302b of nail 302 is anchored to portion 12e of
femur 12 by inserting locking bone screw 308 into portion 12e and
through transverse bore 310a (not shown) of nail 302. Proximal end
302a of nail 302 is anchored to portion 12f of femur 12 by
inserting bone engaging member 306 into portion 12f and through
passageway 340 (defined by aligning opening 338 with opening 312).
Preferably, bone engaging member 306 is initially positioned
adjacent or near second end portion 312b of opening 312. As first
portion 322 of positioning device 304 is rotated in a clockwise
direction, bone engaging member 306 is correspondingly repositioned
along the length of opening 312, and more specifically is
transferred toward first end portion 312a. Because bone engaging
member 306 is anchored to portion 12f of femur 12, portion 12f is
correspondingly moved in the direction of arrow "A", while portion
12e of femur 12 remains stationery, securely anchored to distal end
302b of nail 302. Thus, portion 12f of femur 12 is repositioned
away from portion 12e, thereby distracting fracture site 301.
[0120] One preferred procedure for implanting system 300 within
femur 12 includes forming a longitudinal hole along the medullary
canal from a point generally central to the distal end portion 12d
of femur 12. Preferably this hole is formed by drilling sized to
receive nail 302 therethrough. Positioning device 304 is inserted
in longitudinal passage 314 of nail 302 and nail 302 is inserted
through the longitudinal hole and into the medullary canal. It
should be understood that positioning device 304 could
alternatively be inserted in longitudinal passage 314 after nail
302 has been implanted in femur 12. A first passage is formed
through femur 12 transverse to the medullary canal and generally
aligned with transverse bore 310a (not shown) formed in distal
portion 302b of nail 302. A second passage is formed through femur
12 transverse to the medullary canal and generally aligned with
passageway 340. Preferably, these transverse passages are formed by
drilling. Locking bone screw 308 is threaded into the first
passage, passing through transverse bore 310a. Bone engaging member
306 is threaded into the second passage, passing through passageway
340. At this point, fracture site 301 can be distracted by
following the operational procedure described above. Dashed line
301a of FIG. 15 corresponds to the position of the fractured end of
portion 12f after distraction in accordance with one embodiment of
the present invention.
[0121] Referring now to FIG. 19, intramedullary system 400
according to yet another embodiment of the present invention is
illustrated; where like reference numerals of previously described
embodiments refer to like features. System 400 is shown implanted
in femur 12 and includes elongated intramedullary nail 302,
positioning device 304', bone engaging member 306 and locking bone
screw 308. Femur 12 includes a fracture site 301', separating femur
12 into two portions 12f, 12e. Fracture site 301' is shown in a
distracted state (i.e., portion 12a, 12b are spaced apart relative
to one another). Although system 400 is shown implanted in femur
12, system 400 could also be used in conjunction with other bones
as would occur to one skilled in the art, including the tibia,
humerus, radius, ulna and fibula, to name a few. Additionally, the
same components of system 400 can be used to treat either a left or
right femur by simply rotating nail 302 180 degrees relative to
axis L.sub.6. Although FIG. 19 illustrates nail 302 implanted
within femur 12 in a retrograde direction, it is understood system
400 may also be implanted with nail 302 in an antegrade
direction.
[0122] Referring to FIG. 20, therein is shown nail 302, positioning
member 304' and bone engaging member 306 as assembled within system
400. Positioning member 304' is shown positioned within
longitudinal passage 314 and includes a first portion 402 and a
second portion 404. First portion 402 includes a threaded upper
portion 406 and an elongated lower portion 408 extending therefrom
along longitudinal axis L.sub.6. Upper portion 406 is configured to
threadedly engage threaded portion 318 of longitudinal passage 314.
Upper portion 406 also includes a hex recess 410 for receiving a
driving tool (not shown), such as an Allen wrench. Lower portion
408 has a generally circular body having an outer diameter slightly
less than the diameter of longitudinal passage 314. A transverse
passage 412 extends through lower portion 408 and is aligned
generally perpendicular to axis L.sub.6. The end of lower portion
408 opposite its threaded portion terminates in a generally flat
surface 414.
[0123] Second portion 404 has a circular body having an outer
diameter generally corresponding to the outer diameter of lower
portion 408 of first portion 402. Second portion 404 defines an
internally threaded portion 416 extending generally along axis
L.sub.6 for engaging insertion instrumentation (not shown). One end
of second portion 404 defines a generally flat surface 418,
corresponding to surface 414 of lower portion 408. The opposing end
of second portion 404 terminates in a generally convex outer
surface 420 substantially corresponding to concave bottom surface
316 of longitudinal passage 314. Second portion 404 also defines a
transverse opening 422 extending therethrough generally
perpendicular to axis L.sub.6. Opening 422 is bound by inner
surface 424 and is sized to receive bone engaging member 306
therein.
[0124] FIG. 20 illustrates a first operational position of system
400. Positioning device 304' (including first and second portions
402, 404) is shown inserted within longitudinal passage 314 of nail
302. Opening 422 of second portion 404 is positioned adjacent first
end portion 312a of opening 312 and generally aligned with opening
312 to define a passageway 426. Bone engaging member 306 is shown
inserted through passageway 426. Upper portion 406 of first portion
402 is partially threadedly engaged within threaded portion 318 of
longitudinal passage 314. First portion 402 can be rotated by
placing a driving tool (not shown) within hex recess 410 and
turning first portion 402 in a clockwise or counterclockwise
direction. In one embodiment, threaded upper portion 406 and
threaded portion 318 each have right-handed threads. In this
embodiment, as first portion 402 is rotated in a clockwise
direction, it will be advanced through longitudinal passage 314
generally along axis L.sub.6. As first portion 402 is advanced,
surface 414 will engage surface 418 of second portion 404, thereby
correspondingly advancing second portion 404 through longitudinal
passage 314 generally along axis L.sub.6. As the position of second
portion 404 is adjusted along axis L.sub.6, inner surface 424 of
opening 422 bears against bone engaging member 306 and
correspondingly adjusts the position of bone engaging member 306
along the length of opening 312.
[0125] FIG. 21 illustrates a second operational position of system
400 in which first portion 402 is rotated in a clockwise direction
until bone engaging member 306 is positioned adjacent second end
portion 312b of opening 312. It should be understood, however, that
bone engaging member 306 can be variably positioned anywhere along
the length of opening 312. It should further be understood that the
terms "first operational position" and "second operational
position" are not necessarily indicative of the initial position
and adjusted position of bone engaging member 306. For example,
bone engaging member 306 could originate in a position adjacent
second end portion 312b and be variably positioned anywhere along
the length of opening 312.
[0126] When bone engaging member 306 is positioned adjacent second
end portion 312b of opening 312, transverse passage 412 of upper
portion 406 will become aligned with transverse bore 320 of nail
302, thereby defining a passageway 430. A second bone engaging
member 306 can then be inserted through passageway 430 to prevent
further rotational movement of first portion 402 relative to nail
302. However, if transverse passage 412 and transverse bore 320
cannot be aligned to form passageway 430, a second bone engaging
member 306 cannot be used. In this case, in order to prevent first
portion 402 from rotating and migrating relative to nail 302, a
locking set screw can be threadedly advanced along threaded portion
318 of nail 302 until it tightly engages upper portion 406.
[0127] Having described selected structural and operational
features of positioning device 304', the operational
characteristics of system 400 will now be described in further
detail. Referring back to FIG. 19, nail 302 is shown implanted in
femur 12 and is anchored to portions 12a and 12b in substantially
the same manner as described above in system 300. Preferably, bone
engaging member 306 is initially positioned adjacent or near first
end portion 312a of opening 312. As first portion 402 of
positioning device 304' is rotated in a clockwise direction, bone
engaging member 306 is correspondingly repositioned along the
length of opening 312, and more specifically is transferred toward
second end portion 312b of opening 312. Because bone engaging
member 306 is anchored to portion 12f of femur 12, portion 12f is
correspondingly moved in the direction of arrow "B", while portion
12e of femur 12 remains stationary, securely anchored to distal end
302b of nail 302. Thus, portion 12f of femur 12 is repositioned
toward portion 12e, thereby compressing fracture site 301'. Dashed
line 301b of FIG. 19 corresponds to the fractured end of portion
12f after compression in accordance with one embodiment of the
present invention.
[0128] One preferred procedure for implanting system 400 within
femur 12 is substantially identical to the procedure for implanting
system 300, except a compression operation as described above is
performed instead of the distraction operation as described in
connection with system 300.
[0129] The components of systems 10, 100, 165, 195, 200, 300 and
400 may be fabricated from any suitably strong, bio-compatible
material such as stainless steel, titanium, chrome-cobalt, or any
other material which would occur to those skilled in the art.
[0130] In still further aspects of the invention, there is provided
alternative bone stabilizing components and bone opening
preparation instruments. Referring to FIGS. 22 through 25C, there
is shown a unique bone stabilizing system 500. FIG. 22 illustrates
an intermedullary nail 502 and a cooperable epiphyseal stabilizing
plate 504. Nail 502 includes internally threaded aperture 506
defined between extensions 507. Plate 504 includes aperture 512
which is preferably sized to prevent passage of nail 502. Locking
element 508 is provided and includes an externally threaded posted
510 adapted to pass through aperture 512 and threadedly engage
internally threaded aperture 506. It will be understood that
locking element 508 may be used to interconnect nail 502 to plate
504. While the configuration of a locking member having a smaller
diameter externally threaded post has been disclosed herein as a
preferred embodiment, it will be understood that a portion of nail
502 may be configured with a reduced diameter externally threaded
post that extends through aperture 512 and locking member may be an
internally threaded nut. This and other alternative configurations
of locking arrangements using various locking members may be
utilized with the present invention.
[0131] Plate 504 includes a distal surface 514 disposed on plate
wall 515 that is substantially planar and extends in parallel
alignment with plate longitudinal axis 532. The terms distal and
proximal in reference to plate 504 are utilized to describe those
features having more distal or proximal locations to nail 502 as
shown in FIG. 22. Depending on use and orientation, the same
features could be referred to as upper and lower features. Further,
plate 504 includes opposing longitudinal side walls 516 and 518
extending substantially parallel to longitudinal axis 532. End wall
520 extends between side walls 516 and 518. Side walls 516 and 518
and end wall 520 have a height transverse to the longitudinal axis.
The wall height of the device is substantially greater than plate
wall 515 thickness. As soon in FIG. 22, the difference in wall
height and central-plate thickness defines recess 524. Further,
plate 504 does not include an end wall opposing end wall 520, thus
recess 524 is open adjacent leading end 522. It will be appreciated
(and as shown more clearly in FIG. 25B) that leading end 522 is
defined by side walls 516 and 518, and plate wall 515. Preferably,
the leading edges of each of the defining walls decreases in
thickness such that leading end 522 is configured as a blade to
penetrate bone.
[0132] An alternative plate 550 is shown in FIG. 25A. Plate 550
includes plate wall 560, opposing side walls 562 and 564, and end
wall 566. As previously described with respect to the embodiment
shown in FIG. 22, the combination of these walls define recess 568
shown in FIG. 25B. With further reference to FIG. 25B, plate wall
560 includes a tapered leading edge 561. Similarly, side walls 562
and 564 include tapered leading edges 563 and 565, respectively.
Thus, it will be understood that the leading end 552 is adapted to
penetrate bone or other tissue. As viewed from trailing end 554,
end wall 566 closes recess 568 and may provide a surface for
impaction of the device into the bone. In contrast to the
embodiment of FIG. 22, plate 550 includes a slot 556 that may
variably receive elongated members therethrough. Slot 556 includes
scallops 558 that may selectively engage locking components at any
of the semi-circular apertures along the slot. While a slot and
scallop configuration has been shown as a preferred combination, it
will be understood by those skilled in the art that additional
combinations may be used to provide adjustable fixation, such as
for example but without limitation; serrated washers and plates,
expandable fixation elements, and external clamps.
[0133] FIGS. 23 and 24 shown the apparatus of FIG. 22 inserted into
at least two long bones where the invention may find application.
It will be understood that these examples are provided for the
purpose of illustration and not as a limitation of the use of the
present invention. Referring to FIG. 23, nail 502 has been
positioned within the intermedullary canal of femur 540. Next,
leading end 522 is positioned against the exterior of femur 540
near the tip 503 of nail 502. Plate 504 is aligned with tip 503
such that recess 524 will receive at least a portion of tip 503 as
the plate is advanced into the bone. Longitudinal axis 530 of the
nail and longitudinal axis 532 of the plate are positioned
substantially transverse to each other. With recess 524 in
alignment with tip 503, the trailing wall end 520 may be impacted
to drive plate 504 into the bone. As shown in a preferred
embodiment, plate 504 is advanced into the bone until aperture 512
is in alignment with aperture 506. It will be understood that side
walls 516 and 518 may be spaced to substantially match the diameter
of tip 503 and thereby forming a channel to control movement of
plate 504 relative to nail 502. With appropriate selection of plate
length, end wall 520 may rest against the exterior of femor 540.
With aperture 512 in alignment with aperture 506, locking member
508 may be inserted to join the components one to the other. It is
contemplated that plate 504 and nail 502 may include cooperating
components to prevent rotational movement therebetween.
[0134] FIG. 24 illustrates the apparatus of FIG. 22 inserted into a
tibia 542. Nail 502 is positioned in the intermedullary canal of
tibia 542. Leading edge 522 of plate 520 is aligned with the nail
tip and the plate is driven into the bone by force applied adjacent
end wall 520. Locking member 508 then locks the components
together.
[0135] Another feature of the present invention relates to
preparation of tissue openings to receive fixation devices. More
specifically, reamers have been utilized to prepare intermedullary
canals and other openings to receive implants. It is often assumed
that naturally occurring intermedullary canals are substantially
uniform in bone density radiating outwardly from the longitudinal
axis of a long bone. In some instances these canals have formed in
a non-uniform manner. Further, previous injury to adjacent bone may
result in non-uniform narrowing of the canal as the fracture or
fractures heal. Thus, the present invention provides a reamer that
may be selectively operated to remove bone or other tissue in a
non-cylindrical and non-uniform manner.
[0136] Referring to FIGS. 26A through 26D, there is shown a reaming
head 600 in accordance with a preferred aspect of the present
invention. Although not shown, it will be appreciated that reaming
head 600 will be interconnected with an elongated shaft. Reaming
head 600 includes a truncated cylindrical body 602. As shown in
FIG. 26C, cylindrical body 602 extends approximately 240 degrees
and is interrupted for the remaining 120 degrees by cutting area
607. Cylindrical body 602 defines a maximum outer diameter of the
reaming head 600 and extends in substantial alignment with
longitudinal axis 620. Distal end 605 includes a domed portion 606
substantially continuous with cylindrical body 602. Within cutting
area 607, cutting blade 608 extends in longitudinal alignment with
axis 620. Cutting blade 608 extends along the length opposite
cylindrical body and domed portion 606. Reaming head further
includes cylindrical taper 604 and cylindrical portion 616.
Adjacent proximal end 607 there is a tool attachment mechanism
defined by protrusion 612 and shoulder 614. As shown in FIGS. 26C
and 26D, cannula 610 extends through reamer head in alignment with
longitudinal axis 620.
[0137] In use, reaming head 600 may be interconnected with a shaft
by a tool mechanism cooperable with tool attachment features 612
and 614. The attachment is provides such that the reaming head may
be securely fastened to a shaft and oscillatory motion may be
transmitted to the reaming head. The reaming head 600 may then been
inserted into a bone opening 702 (FIG. 27). In a preferred aspect,
this opening may be an intermedullary canal (although not
completely empty, the tissue density within the canal makes passage
of instruments relatively easy in comparison to the surrounding
cortical bone 700). As shown in FIG. 27, opening 702 has been
narrowed by bone growth 706. It will be understood that a cutting
device providing a uniform cylindrical bone removal may be shifted
off the center (guide wire 710 extends through the center) of the
medullary canal and remove a substantial portion of bone wall 704.
Utilizing reaming head 600, dome 606 and body portion 602 may be
positioned adjacent bone wall 704 while cutting blade is positioned
adjacent bone growth 706. It will be understood that dome 606 tends
to center the reaming head and cylindrical body 602 bears against
the opposing bone wall 704 the operator intends to preserve.
Reaming head 600 may then be oscillated to remove bone growth 706
and restore bone opening 702 to extend in a substantially
centralized position (shown by dashed lines 708) within bone 700.
It is contemplated that reaming head may be oscillated through an
arc of between 20 and 200 degrees although in a preferred aspect
the arc of oscillation is between 80 and 120 degrees. Further, the
oscillator force may be generated by hand force or interconnection
with a power supply as know to those skilled in the art. It will be
appreciated that reaming head 600 may be advanced along a path to
create the desired length of bone opening. Further, reaming head
600 may be utilized to establish an entry opening through the
external cortical bone and into communication with an
intermedullary canal. The present invention may be particularly
useful were surrounding structures tend to force the cutting head
off the intended alignment. Moreover, in a preferred aspect, guide
wire 710 has been positioned along the desired path and confirmed
by X-ray or other visualization. Reaming head 600 is then advanced
along guide wire 710 to remove any bone protrusions that interfere
with its passage through bone opening 702.
[0138] While the invention has been illustrated and described in
detail in the drawings and foregoing discussion, the same is to be
considered as illustrative and not restrictive in character, it
being understood that only the preferred embodiments have been
shown and described and that all changes and modifications that
come within the spirit of the invention are desired to be
protected.
* * * * *